Tinaquant Albumin Gen2 4469658190Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 04015630920587), received between Aug 10, 2018 and Mar 19, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (9 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2026Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT URINE SAMPLE TESTED FOR TINA-QUANT ALBUMIN GEN.2 - URINE APPLICATION ON A COBAS 6000 C501 MODULE. THE INITIAL RESULT WAS <2.6 MG/L. THE REPEAT RESULT WAS 3.5 MG/L. THE SAMPLE WAS REPEATED WITH A RESULT OF 301 MG/L. ON (B)(6) 2026, THE SAMPLE WAS REPEATED WITH A RESULT OF 36.1 MG/L. THE SAMPLE WAS REPEATED FURTHER WITH RESULTS OF <0.9 MG/L, < 0.9 MG/L, <0.7 MG/L AND < 2.9 MG/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24641016 ↗
• MalfunctionJan 8, 2026High Test Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE TINA-QUANT ALBUMIN GEN.2 - URINE APPLICATION ASSAY RESULT FOR A PATIENT SAMPLE TESTED ON A COBAS INTEGRA 400 PLUS W/O ISE. THE INITIAL RESULT WAS 247.4 MG/L. THE REPEAT RESULT WAS 6.6 MG/L. THE REPEAT RESULT WAS DEEMED CORRECT BASED ON THE PATIENT'S MEDICAL HISTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24005357 ↗
• MalfunctionJul 22, 2025Low Test Results; Infusion or Flow Problem; Low Test Results; Infusion or Flow Problem

  THERE WAS AN ALLEGATION OF QUESTIONABLE ALBT2 TINA-QUANT ALBUMIN GEN.2 FOR URINE SAMPLES FROM ONE PATIENT USING A COBAS 8000 COBAS C 502 MODULE. THE INITIAL RESULT WAS <12 MG/L WITH A DATA FLAG. THE FIRST REPEAT RESULT WAS 143 MG/L. THE SECOND AND THIRD REPEAT RESULTS WERE 44 MG/L AND 83 MG/L. THE FIRST REPEAT RESULT WAS QUESTIONED AS IT WAS CONSIDERED TOO HIGH WHICH TRIGGERED THE FURTHER REPEAT TESTING OF THE SAMPLE. NONE OF THE RESULTS WERE REPORTED OUT. IT IS UNKNOWN WHICH RESULTS WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22563902 ↗
• MalfunctionJun 30, 2025Incorrect Measurement; Low Test Results; Incorrect Measurement; Low Test Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE TINA-QUANT ALBUMIN GEN.2 - URINE APPLICATION RESULT FROM THE COBAS 8000 COBAS C 502 MODULE. PATIENT 1'S INITIAL RESULT WAS 0.7 G/L, THE FIRST REPEAT RESULT WAS 24.1 G/L, AND THE SECOND REPEAT RESULT WAS 23.1 G/L. PATIENT 2'S INITIAL RESULT WAS 0.8 G/L, THE FIRST REPEAT RESULT WAS 48.3 G/L, AND THE SECOND REPEAT RESULT WAS 47.0 G/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22357363 ↗
• MalfunctionDec 4, 2024Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 2 PATIENT URINE SAMPLES TESTED FOR ALBT2 TINA-QUANT ALBUMIN GEN.2 (ALBT2) ON A COBAS 8000 C 502 MODULE. PATIENT 1 INITIAL RESULT WAS 27.3 MG/L. THE REPEAT RESULT WAS 0.5 MG/L. PATIENT 2 INITIAL RESULT WAS 191.3 MG/L. THE REPEAT RESULT WAS 12.0 MG/L. IT IS NOT KNOWN WHICH RESULTS WERE BELIEVED TO BE CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20844122 ↗
• MalfunctionAug 9, 2024Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ALBT2 TINA-QUANT ALBUMIN GEN.2 RESULTS FROM THE COBAS 6000 C 501 MODULE. THE CUSTOMER RECEIVED THE SAMPLE FROM A SISTER SITE FOR CORRELATION. THE CUSTOMER'S INITIAL RESULT DID NOT CORRELATE WITH THE SISTER SITE'S RESULT. SPECIFIC DATA FROM THE SISTER SITE WAS NOT PROVIDED. THE INITIAL RESULT WAS <1 MG/DL. THE REPEAT RESULT WAS 21.7 MG/DL. THE CUSTOMER DID NOT KNOW WHICH RESULT WAS CORRECT AND DID NOT PROVIDE INFORMATION ABOUT WHICH RESULT WAS REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19953846 ↗
• MalfunctionMar 26, 2024Insufficient Device Problem Information; Non Reproducible Results; Insufficient Device Problem Information; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ALBT2 TINA-QUANT ALBUMIN GEN.2 (MICROALBUMIN) ON A COBAS 6000 C501 MODULE. THE SAMPLE INITIALLY RESULTED IN A MICROALBUMIN VALUE OF 32.500 MG/L AND IT REPEATED AS 11.900 MG/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18980530 ↗
• MalfunctionSep 28, 2023Low Test Results; Low Test Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE ALBT2 TINA-QUANT ALBUMIN GEN.2 (ALB) RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 8000 COBAS C 502 MODULE. THE INITIAL RESULT WAS VALIDATED BY THE LABORATORY INFORMATION SYSTEM (LIS) OF THE HOSPITAL. IT WAS POSSIBLE THAT IT WAS VIEWED BY THE PHYSICIAN. THE REPORTER WAS SUSPICIOUS OF THE LOW RESULT WHICH PROMPTED THE RERUN OF THE PATIENT SAMPLE. THE REPORTER RERAN THE PATIENT SAMPLE ON THE MODULE AND THEIR OTHER 502 MODULE. THEY PERFORMED MAINTENANCE ON THE REPORTED MODULE BEFORE RERUNNING THE PATIENT SAMPLE. THE INITIAL RESULT FROM THE MODULE WAS 17.5 G/L. THE FIRST REPEAT RESULT FROM THE OTHER MODULE WAS 27.1 G/L. THE SECOND REPEAT RESULT FROM THE OTHER MODULE WAS 27.7 G/L. THE THIRD REPEAT RESULT FROM THE MODULE WAS 29.3 G/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17836363 ↗
• MalfunctionDec 6, 2022Low Test Results; Low Readings; Low Test Results; Low Readings

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT URINE SAMPLE TESTED WITH ALBT2 TINA-QUANT ALBUMIN GEN.2 (MICROALBUMIN) ON A COBAS 6000 C (501) MODULE. NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN A MICROALBUMIN VALUE OF 324.8 MG/L. THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF < 0.7 MG/L WITH A DATA FLAG. THE SAMPLE WAS ALSO REPEATED ON (B)(6) 2022, RESULTING IN A VALUE OF < 0.8 MG/L WITH A DATA FLAG. THE MICROALBUMIN REAGENT LOT NUMBER WAS 65268801. THE REAGENT EXPIRATION DATE WAS REQUESTED, BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15926561 ↗
• MalfunctionDec 5, 2022High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 2 PATIENT URINE SAMPLES TESTED FOR ALBT2 TINA-QUANT ALBUMIN GEN.2 (ALBT2) ON A COBAS 6000 C (501) MODULE. PATIENT 1 INITIAL RESULT WAS 63.3 MG/L. THIS RESULT WAS NOT CONSISTENT WITH OTHER RESULTS FOR THE SAMPLE SO THE LABORATORY REPEATED THE SAMPLE ON A DIFFERENT ANALYZER (METHOD UNKNOWN) AND THE RESULT WAS "NORMAL." ON (B)(6) 2022 THE SAMPLE WAS REPEATED TWICE ON THE C501 MODULE WITH RESULTS OF 0.3 MG/L WITH A DATA FLAG. ANOTHER RESULT FROM THE SAMPLE WAS PROVIDED OF 20.4 MG/L. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. PATIENT 2 INITIAL RESULT WAS 23 MG/L. THE SAMPLE WAS REPEATED TWICE WITH RESULTS OF 14 MG/L AND 22 MG/L. IT IS NOT CLEAR WHICH RESULTS ARE BELIEVED TO BE CORRECT. THE ALBT2 REAGENT LOT NUMBER IS 59240101 WITH AN EXPIRATION DATE OF 30-SEP-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15914798 ↗
• MalfunctionNov 20, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER STATED THEY HAVE BEEN HAVING ONGOING ISSUES WITH PATIENT SAMPLE RECOVERY FOR ALBT2 TINA-QUANT ALBUMIN GEN.2 ON THE COBAS 6000 C (501) MODULE. THE FIELD SERVICE ENGINEER HAD BEEN OUT TWICE TO ADDRESS THE ISSUE AND ALL PROBES WERE CHANGED ON ONE OF THE VISITS. THE CUSTOMER STATED THE ISSUE SEEMED TO START AFTER USING A NEW LOT OF CALIBRATOR. DATA WAS PROVIDED FOR 5 PATIENT SAMPLES TESTED FOR MICROALBUMIN. THE INITIAL VALUES WERE MEASURED EITHER ON (B)(6) 2022 OR(B)(6)2022 AND WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLES WERE REPEATED ON (B)(6)2022. THE CUSTOMER DID NOT KNOW WHICH VALUES WERE CORRECT. THE CUSTOMER STATED THAT THE FIRST TWO SAMPLES WERE TESTED PRIOR TO THE VISITS FROM THE ENGINEER. SAMPLES 3-5 WERE TESTED AFTER THE VISITS FROM THE ENGINEER. THE FIRST SAMPLE INITIALLY RESULTED IN A MICROALBUMIN VALUE OF < 12 MG/L WITH A DATA FLAG. THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 22 MG/L. THE SECOND SAMPLE INITIALLY RESULTED IN A MICROALBUMIN VALUE OF 106.3 MG/L. THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 22.1 MG/L. THE THIRD SAMPLE INITIALLY RESULTED IN A MICROALBUMIN VALUE OF < 12 MG/L WITH A DATA FLAG. THE SAMPLE WAS REPEATED, RESULT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15831281 ↗
• MalfunctionNov 8, 2022High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR 5 PATIENT URINE SAMPLES TESTED WITH ALBT2 (TINA-QUANT ALBUMIN GEN.2) ON A COBAS 6000 C (501) MODULE. PATIENT 1: THE SAMPLE INITIALLY RESULTED IN A VALUE OF 18.26 MG/DL. THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE PHYSICIAN QUESTIONED THE RESULT TOGETHER WITH TWO ADDITIONAL ALBT2 PATIENT RESULTS OBTAINED ON THE SAME DAY. THE SAMPLE FROM PATIENT 1 WAS REPEATED ON A SECOND ANALYZER RESULTING IN A VALUE OF 13.68 MG/DL. THE CUSTOMER THEN REPEATED 20 SAMPLES FROM THE SAME DAY AND NOTED DISCREPANT ALBT2 RESULTS FOR 4 ADDITIONAL PATIENT SAMPLES. PATIENT 2: THE SAMPLE INITIALLY RESULTED IN A VALUE OF 18.66 MG/DL. THE SAMPLE WAS REPEATED ON A SECOND ANALYZER RESULTING IN A VALUE OF 1.29 MG/DL. PATIENT 3: THE SAMPLE INITIALLY RESULTED IN A VALUE OF 31.57 MG/DL. THE SAMPLE WAS REPEATED ON A SECOND ANALYZER RESULTING IN A VALUE OF 0.63 MG/DL. PATIENT 4: THE SAMPLE INITIALLY RESULTED IN A VALUE OF 4.08 MG/DL. THE SAMPLE WAS REPEATED ON A SECOND ANALYZER RESULTING IN A VALUE OF <0.40 MG/DL ACCOMPANIED BY A DATA FLAG. PATIENT 5: THE SAMPLE INITIALLY RESULTED IN A VALUE OF 18.18 MG/DL. THE SAMPLE WAS REPEATED ON A S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15754758 ↗
• MalfunctionNov 7, 2022Low Test Results; Low Test Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT URINE SAMPLE TESTED FOR ALBT2 TINA-QUANT ALBUMIN GEN.2 (ALBT2) ON A COBAS 8000 C 502 MODULE. THE CUSTOMER FIRST TESTED THE SAMPLE MANUALLY USING A TEST STRIP AND THE RESULT WAS "POSITIVE." THE CUSTOMER THEN RAN THE SAMPLE ON THE C502 MODULE USING AN X50 DILUTION WITH A RESULT OF 14.0 MG/L. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULT USING AN X20 DILUTION WAS 1411.6 MG/L. ON (B)(6) 2022 THE SAMPLE WAS REPEATED USING AN X10 DILUTION AND THE RESULT WAS 1410.3 MG/L. THE C502 MODULE SERIAL NUMBER WAS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15742544 ↗
• MalfunctionOct 25, 2022High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ALBT2 TINA-QUANT ALBUMIN GEN.2 RESULTS FOR 2 PATIENT SAMPLES ON A COBAS 6000 C501 MODULE. FOR SAMPLE 1, THE INITIAL ALBUMIN RESULT WAS 77.4 MG/L. THE REPEAT RESULT WAS 19.3 MG/L. FOR SAMPLE 2, THE INITIAL ALBUMIN RESULT WAS 88 MG/L. THE REPEAT RESULT WAS 41.4 MG/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REAGENT LOT IS 65268801 AND THE EXPIRATION DATE IS 30-APR-2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15668838 ↗
• MalfunctionOct 17, 2022Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE ALBT2 TINA-QUANT ALBUMIN GEN.2 RESULT FOR ONE URINE PATIENT SAMPLE TESTED ON THE COBAS 6000 C 501 MODULE. THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE DOCTOR QUESTIONED THE RESULT WHICH PROMOTE A RERUN OF THE PATIENT SAMPLE. ON (B)(6) 2022, THE INITIAL RESULT WAS 14.66 MG/DL. ON (B)(6) 2022, THE FIRST REPEAT RESULT WAS 67.98 MG/DL WITH A DATA FLAG THAT INVALIDATED THE RESULT. THE SECOND REPEAT RESULT USING DECREASED MODE WAS 414.92 MG/DL. THIS REPEAT RESULT WAS DEEMED CORRECT. THE REAGENT LOT NUMBER IS 641706. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15620462 ↗
• MalfunctionMay 16, 2022Incorrect Measurement; Low Test Results; Incorrect Measurement; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ALBT2 TINA-QUANT ALBUMIN GEN.2 ON TWO COBAS 6000 C (501) MODULE ANALYZERS. NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS PROCESSED ON A MODULAR PRE-ANALYTICS SYSTEM AND AN ALIQUOT OF THE SAMPLE WAS TESTED ON C 501 SERIAL NUMBER (B)(4), RESULTING IN A MICROALBUMIN VALUE OF 188.1 MG/L. THE SAMPLE WAS REPEATED ON C 501 ANALYZER SERIAL NUMBER (B)(4), RESULTING IN A MICROALBUMIN VALUE OF 138.8 MG/L ACCOMPANIED BY A DATA FLAG (>PROZ) INDICATING THE MEASUREMENT WAS OUTSIDE OF THE PROZONE LIMIT PROGRAMMED FOR THE APPLICATION. THE SAMPLE WAS AUTOMATICALLY REPEATED BY THE SAME ANALYZER USING A DECREASED SAMPLE VOLUME, RESULTING IN A VALUE OF 6421.4MG/L ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS MANUALLY DILUTED 1:2 AND 1:5 AND REPEATED ON EACH ANALYZER. ON C 501 SERIAL NUMBER (B)(4), THE 1:2 DILUTED SAMPLE INITIALLY RESULTED IN A MICROALBUMIN VALUE OF 610.7 MG/L ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS REPEATED ON THE SAME ANALYZER AT A DECREASED SAMPLE VOLUME, RESULTING IN A RAW VALUE OF 3860.0 MG/L, WHICH CALCULATES TO A FINAL VALUE OF 7720 MG/L WHEN ACCOUNTING F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14406690 ↗
• MalfunctionMay 7, 2022Low Test Results; Low Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE URINE ALBT2 TINA-QUANT ALBUMIN GEN.2 (MICROALBUMIN) RESULTS FOR ONE PATIENT TESTED ON A COBAS 8000 C 502 MODULE WITH SERIAL NUMBER (B)(4). THE PATIENT'S INITIAL MICROALBUMIN RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENT'S DOCTOR DID NOT BELIEVE THE REPORTED MICROALBUMIN RESULT. THE CUSTOMER PERFORMED REPEAT TESTING WITH THE PATIENT'S SAMPLE ON THE C 502 MODULE AND AN OPTILITE ANALYZER. ON (B)(6) 2022, THE PATIENT'S INITIAL MICROALBUMIN RESULT WAS 0.247 G/L. ON (B)(6) 2022, THE PATIENT'S MICROALBUMIN RESULT ON THE OPTILITE ANALYZER WAS 6.8 G/L. ON (B)(6) 2022, THE PATIENT'S REPEAT MICROALBUMIN RESULT WAS 0.223 G/L. THIS RESULT WAS REPORTED TO THE PATIENT'S DOCTOR. ON (B)(6) 2022, THE PATIENT'S REPEAT MICROALBUMIN RESULT WITH A 1:11 DILUTION WAS 6.277 G/L WITH A DATA FLAG. ON (B)(6) 2022, THE PATIENT'S REPEAT MICROALBUMIN RESULT WITH A 1:50 DILUTION WAS 6.879 G/L. THE CUSTOMER DETERMINED THE CORRECT RESULTS FOR THE PATIENT WERE 6.8 G/L, 6.277 G/L, AND 6.879 G/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14322882 ↗
• MalfunctionAug 10, 2018Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER STATED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE 24 HOUR URINE PATIENT SAMPLE TESTED FOR ALBT2 TINA-QUANT ALBUMIN GEN.2 ON A COBAS INTEGRA 400 PLUS (I400+). THE SAMPLE INITIALLY RESULTED WITH AN ALBT2 VALUE OF 144.182 MG/L AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY TO THE PATIENT. THE PATIENT QUESTIONED THE RESULT SINCE IT WAS ELEVATED AND A PHYSICIAN ASKED FOR A REPEAT OF THE SAMPLE. THE SAMPLE WAS REPEATED ON (B)(6) 2018, RESULTING AS 148.331 MG/L. THE SAMPLE WAS DILUTED (DILUTION FACTOR UNKNOWN) AND REPEATED FIVE MORE TIMES ON (B)(6) 2018, RESULTING AS 1234.98 MG/L, 1283.99 MG/L, 1278.84 MG/L, 1295.05 MG/L, AND 1270.67 MG/L. THE SAMPLE WAS DILUTED 1:10 AND REPEATED ON (B)(6) 2018, RESULTING AS 1301.479 MG/L. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE SERIAL NUMBER OF THE I400+ WAS (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7773678 ↗